Dr. Donald S. Fredrickson 
September 22, 1978 
Page 2 
the terms "hazards" or "risks," and should appear uniformly throughout 
the PRG-NIH. While this may only be semantic, I believe that it 
more precisely reflects our current knowledge and understanding. 
3. I specifically want to express my strong approval for the change that 
will enable non-NIH funded institutions (section IV-C-2 and Appendix 
C, IV-C) to seek the advice and council of RAC, ORDA and the Office 
of Research Safety, NCI (section IV-C-2) . This section will aid our 
ability to comply with the specifics as well as the intent of the 
PRG-NIH . 
4. One portion of section IV-A-2, which deals with the membership of 
institutional biosafety committees, may pose a particular problem 
for private industry. PRG-NIH precludes any member of an IBC from 
participating in the review or approval of a project in which he/she 
has direct financial interest. In an effort to prevent possible 
conflicts of interest (clearly, a desirable goal) , PRG-NIH could be 
interpreted as requiring all decisions to be made by "noninstitutional" 
IBC members. Since all management, directors, scientists and staff 
of a private corporation could or would have direct financial interest 
in any scientific project carried out by their firm, I suggest that 
the term "direct financial interest" be eliminated at least as far 
as private industry is concerned. 
5. There is an aspect of PRG-NIH which I find a disturbing departure 
from both the 1976 guidelines and PRG-RAC. While I thoroughly sup- 
port the effort to involve the public and to seek wide input for 
discussions of policy, I can find little reason to require public 
comment and response for purely scientific evaluations (e.g., I-E-4, 
IV-B-l-c, IV-B-l-d) . Furthermore, while more decentralization in 
certain areas appears in PRG-NIH (e.g., IV-A-2-a, IV-A-2-b) , in other 
areas there appears to be a substantial shift in decision-making 
power to ORDA and the Director exclusively that seem both unnecessary 
and unwise. Your Decision Document specifically states, "Flexibility, 
however, remains essential to avoid unnecessary and protracted delays 
in decision making." For example, it seems very likely that a very 
large number of new HV1 vectors will be proposed for many recombinant 
DNA experiments. A more flexible approach (than requiring approval, 
publication for comment, public hearings, and finally certification for 
HV1!) would permit RAC to approve and certify new HV1 host vector 
systems based on the requirements in PRG-NIH after review of the 
submitted scientific evidence. 
Similarly, I believe that unwarranted delays could be avoided if 
program directors for NSF, DOE, USDA, etc. sponsored recombinant DNA 
research projects similarly were able to authorize use of alternate 
HV1 systems after seeking the advice of RAC or some other scientific 
[A-264] 
